Saturday, March 2, 2024

CATEGORY

Regulatory Agencies

Bayer’s Lung Cancer Treatment Earns FDA Breakthrough Therapy Designation

Bayer's innovative small molecule tyrosine kinase inhibitor (TKI) BAY 2927088 has received Breakthrough Therapy designation from the FDA for the treatment of unresectable or...

Expanding Horizons in Multiple Myeloma Treatment: CHMP Backs Earlier Application of Carvykti CAR-T Therapy

European drug regulators have given their endorsement for Johnson & Johnson (J&J) and Legend Biotech’s Carvykti to be used earlier in the multiple myeloma...

Simlandi’s Approval Revolutionizes Biosimilar Landscape: A Game-Changer for Humira’s Dominance

Pharmacists in the United States are now granted the authority to substitute a more affordable biosimilar version for AbbVie's high-concentration formulation of Humira without...

SeaStar’s Device Receives Humanitarian Device Exemption Status to Aid Children with AKI

In the wake of encouraging clinical results, SeaStar Medical, a pioneering entity in the medical device industry, has garnered approval from the prestigious US...

Ensysce Nears Milestone in Opioid Medication Safety with Promising FDA Discussions on PF614-MPAR

Ensysce Biosciences, a leading innovator in the field of clinical-stage pharmaceutical development, has announced significant progress following a constructive meeting with the Food and...

Artiva’s Lupus Nephritis Treatment AlloNK Gets FDA New Drug Application Approval

Artiva has received FDA clearance for their investigational new drug application for lupus nephritis treatment AlloNK plus rituximab, marking the first IND clearance for...

FDA Priority Review for Breakthrough Biologic Therapy: Dupixent Eyes New Frontier in COPD Treatment

Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application...

FDA Awards Second Orphan Drug Designation to IO-202 for Leukemia Treatment

Immune-Onc Therapeutics has recently reached an important benchmark in the advancement of its pioneering treatment, IO-202, with the Food and Drug Administration (FDA) bestowing...

Italian Medicines Agency Undergoes Major Organizational Restructuring

The Italian Ministry of Health has enacted significant reforms in the structure of the Italian Medicines Agency (AIFA) through Decree 3/2024, published in the...

FDA Warns Medical Device Companies Against Unreliable Third-Party Lab Data in Submissions

The FDA has issued a statement urging medical device companies to carefully assess the reliability of third-party testing data before submitting it to the...

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